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Trial registered on ANZCTR


Registration number
ACTRN12609000631202
Ethics application status
Approved
Date submitted
27/07/2009
Date registered
28/07/2009
Date last updated
24/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Are patient competencies in managing chronic conditions improved using the Flinders self-management approach?
Scientific title
In people aged 45 and over with one or more chronic conditions, does the Flinders care planning program in addition to usual care, in comparison with usual care alone, improve patient competencies in chronic condition self-management
Secondary ID [1] 284322 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ischaemic heart disease 237123 0
congestive cardiac failure 237124 0
transient ischaemic attacks 237127 0
chronic obstructive pulmonary disease (COPD) 237128 0
diabetes 237365 0
Condition category
Condition code
Public Health 237450 237450 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Flinders Program for Chronic Care Management

The Flinders Program provides a generic set of tools and processes that enables health workers and patients to undertake a structured process that provides assessment of self-management behaviours, collaborative identification of problems and goal-setting, leading to the development of individualised longitudinal (12 month) care plans.

For the trial, the Flinders Program will be delivered as an initial care planning session between the client and a health professional who has been trained in using the Program. The health professional will provide follow up 2-4 weekly for up to 6 months to monitor progress, provide feedback and motivation, and problem solving training to assist the client to achieve their goals and enhance their self-management.

Participants in this group also receive usual care for the duration of the Flinders Program and until the end of the trial.
Intervention code [1] 236845 0
Behaviour
Comparator / control treatment
Usual care

Those who are allocated to usual care will receive the usual set of services provided to people with chronic conditions. These include a range of nursing and allied health services, e.g., diabetes education, asthma education, podiatry, nutrition advice, physiotherapy, and occupational therapy.

Participants in this arm will be followed while receiving these services for the duration of the trial, ie up to 18 months.
Control group
Active

Outcomes
Primary outcome [1] 238252 0
Self-management competencies as measured by the Partners in Health Scale score
Timepoint [1] 238252 0
Baseline and 6 and up to 12 and 18 months after intervention commenced
Secondary outcome [1] 244593 0
Health-related quality-of-life as measured by the SF-12 (v2) score
Timepoint [1] 244593 0
Baseline and 6 and up to 12 and 18 months after intervention commenced
Secondary outcome [2] 244979 0
Self-efficacy for managing chronic disease as measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale (Stanford Patient Education Research Centre)
Timepoint [2] 244979 0
Baseline and 6 and up to 12 and 18 months after intervention commenced
Secondary outcome [3] 244980 0
Health distress as measured by the Health Distress scale (Stanford Patient Education Research Centre)
Timepoint [3] 244980 0
Baseline and 6 and up to 12 and 18 months after intervention commenced
Secondary outcome [4] 244981 0
Energy/fatigue as measured by the Energy/Fatigue scale (Stanford Patient Education Research Centre)
Timepoint [4] 244981 0
Baseline and 6 and up to 12 and 18 months after intervention commenced

Eligibility
Key inclusion criteria
People aged 45 years and over with one or more chronic conditions
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to read and understand English language information and consent form, burdensome physical or mental distress, dementia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone call to hospital pharmacy where allocation schedule held
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with randomly varied block size, generated using STATA statistical software, stratified by referral source (hospital or community clinic)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2009
Actual
31/08/2009
Date of last participant enrolment
Anticipated
Actual
26/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237235 0
Government body
Name [1] 237235 0
Australian Government, Department of Health and Aging
Country [1] 237235 0
Australia
Primary sponsor type
Individual
Name
Professor Malcolm Battersby
Address
Department of Psychiatry
Flinders University
PO Box 2100
Adelaide
SA 5001
Country
Australia
Secondary sponsor category [1] 236723 0
None
Name [1] 236723 0
Address [1] 236723 0
Country [1] 236723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239530 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 239530 0
Ethics committee country [1] 239530 0
Australia
Date submitted for ethics approval [1] 239530 0
Approval date [1] 239530 0
Ethics approval number [1] 239530 0
1/09/0164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29822 0
Prof Malcolm Battersby
Address 29822 0
Department of Psychiatry
Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 29822 0
Australia
Phone 29822 0
+60 8 8404 2314
Fax 29822 0
Email 29822 0
malcolm.battersby@flinders.edu.au
Contact person for public queries
Name 13069 0
Dr Melanie Harris
Address 13069 0
Flinders Human Behaviour and Health Research Unit

Flinders University

PO Box 2100, Adelaide, South Australia 5001
Country 13069 0
Australia
Phone 13069 0
+61 8 84042320
Fax 13069 0
+61 8 84042101
Email 13069 0
melanie.harris@flinders.edu.au
Contact person for scientific queries
Name 3997 0
Dr Melanie Harris
Address 3997 0
Flinders Human Behaviour and Health Research Unit

Flinders University

PO Box 2100, Adelaide, South Australia 5001
Country 3997 0
Australia
Phone 3997 0
+61 8 84042320
Fax 3997 0
+61 8 84042101
Email 3997 0
melanie.harris@flinders.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.